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IBELULA™: An Open-label, Single-arm, Multi-center, Phase 3 Study on the Efficacy, Safety, and Pharmacokinetics of Debio 4326, a Triptorelin 12-month Formulation, in Pediatric Participants With Central Precocious Puberty

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Trial Profile

IBELULA™: An Open-label, Single-arm, Multi-center, Phase 3 Study on the Efficacy, Safety, and Pharmacokinetics of Debio 4326, a Triptorelin 12-month Formulation, in Pediatric Participants With Central Precocious Puberty

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 21 May 2025

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At a glance

  • Drugs Debio 4326 (Primary)
  • Indications Precocious puberty
  • Focus Registrational; Therapeutic Use
  • Acronyms IBELULA; LIBELULA
  • Sponsors Debiopharm

Most Recent Events

  • 14 May 2025 Planned number of patients changed from 53 to 56.
  • 14 May 2025 Planned End Date changed from 1 Mar 2028 to 1 Feb 2028.
  • 14 May 2025 Planned primary completion date changed from 1 Dec 2026 to 1 Nov 2026.

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